Metronidazole Tablets USP 400 mg Technical Specification:
| Product Name: | Metronidazole Tablets USP 400 mg |
| Brand Name: | Generic |
| Strength: | 400mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 21s, 100s, 200s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Antibiotic, Antimicrobial, Antibacterial |
| Indication: | To treat a wide variety of infections |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Metronidazole Tablets USP 400 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Metronidazole Tablets USP 400 mg
Each Film Coated Tablet Contains
Metronidazole USP…………………..400 mg
Excipients……………………………….Q.S.
THERAPEUTIC INDICATIONS:
This medication is used to treat skin infections, rosacea and mouth infections, including infected gums and dental abscesses, bacterial vaginosis, trichomoniasis, pelvic inflammatory disease (PID), giardiasis and Clostridium difficile infection.
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
WARNING:
Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should therefore be avoided.
TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
STORAGE: Store in cool and dry place below 30°C.
DOSAGE: As directed by the Physician.